FOR IMMEDIATE RELEASE
WASHINGTON, D.C., May 31, 2019 – Jacqueline French, M.D., chief medical and innovation officer of the Epilepsy Foundation and professor of neurology at NYU Langone Health's Comprehensive Epilepsy Center, testified today at the U.S. Food & Drug Administration's (FDA) Public Hearing on Scientific Data and Information about Products Containing Cannabis or Cannabis-Derived Compounds in support of regulations to ensure safe and continued access to therapeutic cannabidiol (CBD) products. The hearing seeks to obtain data and information about the safety, manufacturing product quality, marketing, labeling and sale of cannabis or cannabis-derived products. This comes after legislation was enacted to federally legalize hemp including hemp-derived CBD with 0.3% or less THC by dry weight in late 2018. The Epilepsy Foundation is committed to supporting physician-directed and person-centered care, and to exploring and advocating for all potential treatment options for epilepsy, including CBD.
"We are grateful to have the opportunity to testify and explain the unique needs of people with epilepsy," said Dr. French. "More research is certainly needed to understand the effectiveness of CBD to treat epilepsy and seizures, but in the interim, abruptly losing access to these products, as with many other anti-seizure medications, may put the health and well-being of people with epilepsy at great risk. We are recommending additional safeguards on product consistency and labeling."
Currently, more than one-third of people living with epilepsy do not achieve seizure control with available medications. There are also many people living with significant side-effects from their current treatment. Many people in the epilepsy community turn to CBD oil to help control their seizures or for its therapeutic effects that help combat devastating side-effects.
"If an individual and their healthcare team feel that the potential benefits of CBD outweigh the risks, those individuals should have meaningful access to safe, consistent and regulated therapeutic CBD products," said Philip M. Gattone, M.Ed., president and CEO of the Epilepsy Foundation.
Significant advancement was achieved in 2018 when the FDA approved EPIDIOLEX® for seizures associated with Dravet syndrome and Lennox-Gastaut Syndrome, two rare and severe forms of epilepsy. However, it has a narrow indication and is not widely available for use.
On behalf of the Epilepsy Foundation, Dr. French urged the FDA to preserve access to therapeutic levels of CBD for those who need it as life-saving medication and to enact regulations that ensure the safety and consistency of available products.
The May 31st FDA hearing is solely gathering information. Decisions and regulations will take time.
Read the comment the Foundation submitted to the FDA here.
According to the World Health Organization, epilepsy is the most common serious brain disorder worldwide with no age, racial, social class, national or geographic boundaries. The U.S. Centers for Disease Control & Prevention (CDC) estimates that 3.4 million people in the United States are affected by epilepsy. It is the underlying tendency of the brain to produce seizures which are sudden abnormal bursts of electrical energy that disrupt brain functions.
About the Epilepsy Foundation
With a network of nearly 50 partners throughout the United States, the Foundation connects people to treatment, support and resources; leads advocacy efforts; funds innovative research and the training of specialists; and educates the public about epilepsy and seizure first aid. For more than five decades, the Epilepsy Foundation has shone a light on epilepsy to promote awareness and understanding, and to advocate for laws that matter to people with epilepsy, while also funding $65 million for epilepsy research and supporting 3,076 epilepsy investigators and specialists in their early careers. Over the past 17 years, in partnership with the CDC, the Epilepsy Foundation has helped to improve access to care for people with epilepsy, expanded its digital reach and online resources in homes across the country, and trained more than 500,000 school and community personnel in how to recognize seizures and administer seizure first aid. The Foundation has also assisted more than 108,000 people through its 24/7 Helpline in the past five years, and continues to focus on innovation, new therapies, community services, advocacy and education as key priorities. To learn more visit epilepsy.com or call 1.800.332.1000. Follow us on Facebook and Twitter.
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